AssayIndex

AX-2025-020275

5-Amino-1MQ · 100 mg declared · Xi'an Mokemei Biotechnology Co., Ltd. · lot MKM-2506-T2989

FAILVERIFIED
Report ID
AX-2025-020275
Compound
5-Amino-1MQ
Compound class
Non-peptide adjuncts
Supplier
MKM — Xi'an Mokemei Biotechnology Co., Ltd.
Batch / lot
MKM-2506-T2989
Declared label claim
100mg
Laboratory
Nordanalyt Laboratories
Assay date
07 Dec 2025
Submitted
18 Dec 2025
Quarter
2025-Q4
Submitter
b.delgado
Sample provenance
Supplier-supplied
Section 1

Results

Measured against the index acceptance specification for the non-peptide adjuncts class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 35 min gradient, 214 nm98.68% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.32% area≤ 2.0PASS
Largest single impurityRP-HPLC — 1-methylquinolinium (des-amino, −15 Da)0.53% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula285.9967DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)285.9965DaNOT TESTED
Mass accuracyobserved vs theoretical-0.7ppm± 10PASS
Total peptide contentby difference from the gravimetric mass balance55.89%w/wNOT TESTED
Target-compound contenttotal peptide content × purity55.15%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen169.45mg100 mg declaredNOT TESTED
Recovered target peptidegross fill × target content93.452mg100 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim93.5%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate6.58%≤ 10.0PASS
Counter-ion (iodide)anion-exchange ion chromatography36.96%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.57%NOT TESTED
Endotoxinnot ordered on this submissionnot determined≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration6.292.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient6.29min6.25 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.130.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²65,874≥ 20,000PASS
Resolution to nearest impurityvs free iodide (counter-ion, by IC)0.00no index criterionREPORTED
Section 2

Chromatogram and peak integration

The figure is drawn from the table. It is not an independent illustration — if a number in the table changed, the trace would change with it.

0438487671315117535 5-Amino-1MQ6.29 min · 98.68 % 5.92 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0510152025303540 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 35 min gradient, 214 nm. Drawn from the peak-integration table below: peak positions are the reported retention times, peak areas are the reported area percentages, peak widths follow the reported plate count of 65,874, and skew follows the reported asymmetry factor of 1.13. Baseline noise is seeded from the report ID and is illustrative. The lower panel is the same trace at a stated vertical expansion with the slow gradient drift subtracted, because at full scale a 0.53 % impurity against a 98.68 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
15-Amino-1MQ — main peak6.294,796,15498.68
21-methylquinolinium (des-amino, −15 Da)5.9225,7600.53-15.011
38-amino regioisomer6.5523,8160.490.000
4free iodide (counter-ion, by IC)6.297,7760.160.000
55-nitro-1MQ (unreduced precursor, +30 Da)7.086,8040.14+29.974
Closure check — purity + Σ impurities 100.00CLOSES

Reporting threshold 0.05 % area. Peaks below it are not reported and are therefore excluded from the total, which overstates purity by their sum — see peak integration.

Section 3

Mass spectrum and identity

Theoretical monoisotopic mass 285.9967 Da, computed from C10H11N2+ · I−. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100250275300325350375 [M+1H]1+287.00 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 285.9965 Da. Sodium (+21.982/z) and potassium (+37.956/z) adducts are shown where the parent charge state exceeds 25 % relative abundance; they are adducts of the same molecule and are not impurities.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
1+287.0040287.0038-0.0002100.0
Section 4

Gravimetric mass balance

Water, counter-ion, residual and total peptide content are exhaustive and mutually exclusive categories. They must account for 100 % of the cake mass. The index closes this to within 0.02 pp and the build asserts it.

ComponentDetermination%w/w of cake
WaterKarl Fischer6.58
Counter-ion (iodide)ion chromatography36.96
Residual solvent + inorganic residueestimated0.57
Total peptide contentby difference55.89
Total100.00 CLOSES

Supplier certificate, as declared

The supplier's own figures for this lot, beside the independent measurement. Divergence is assessed against the batch median, not against this single report — see rule AX-R05.

FigureSupplier COAThis reportIndex note
Purity (% area)99.5998.68divergence +0.50 pp vs batch median
Total impurities (% area)not stated1.32
Largest single impurity (% area)not stated0.53
Water (%)5.46.58
Counter-ion (%)not stated36.96
Peptide content (%w/w)89.855.89
Endotoxin (EU/mg)not statednot determined
Method stated on certificateYEScolumn, gradient and wavelength given
Section 5

Provenance and caveats

Where a sample came from changes the weight of the evidence. The index treats it as a first-class field.

Sample provenance
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 4 d) → assay. Submitter did not handle the vial.
Assay date
07 Dec 2025
Submitted to the index
18 Dec 2025
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot MKM-2506-T2989 n=7

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020271MKM-2506-T2989Janoshik2025-Q498.776.45Supplier-supplied1FAIL
AX-2026-042909MKM-2506-T2989Kestrel2025-Q499.106.4699.9Supplier-supplied1FAIL
AX-2026-042910MKM-2506-T2989Medutest2025-Q498.996.67103.1Supplier-supplied1FAIL
AX-2025-020272MKM-2506-T2989Janoshik2025-Q499.096.23Supplier-supplied2FAIL
AX-2025-020273MKM-2506-T2989Janoshik2025-Q499.126.15Supplier-supplied1FAIL
AX-2025-020274MKM-2506-T2989Kestrel2025-Q499.586.0598.7Supplier-supplied2FAIL
Other recent 5-Amino-1MQ records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042753GGPepsGGPE-2512-M9695Medutest2026-Q299.214.6193.5Supplier-supplied2FAIL
AX-2026-042970KPKP-2511-W4792Janoshik2026-Q298.894.0391.0Supplier-supplied2FAIL
AX-2026-042969KPKP-2511-W4792Janoshik2026-Q299.333.94Buyer-sourced2FAIL
AX-2026-042967KPKP-2511-W4792Janoshik2026-Q299.494.14Supplier-supplied2FAIL
AX-2026-042754GGPepsGGPE-2512-M9695PeptideMeter2026-Q299.204.9096.8Supplier-supplied2FAIL
AX-2026-042971KPKP-2511-W4792Janoshik2026-Q299.454.19107.1Supplier-supplied2FAIL
AX-2026-042968KPKP-2511-W4792Janoshik2026-Q298.874.3291.5Buyer-sourced2FAIL
AX-2026-042012TFCTFC-2508-L6321Janoshik2026-Q199.935.8495.7Supplier-supplied0FAIL
Other recent MKM records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042943AdipotideMKM-2606-K4013Janoshik2026-Q397.926.31Supplier-supplied1MARGINAL
AX-2026-042891CJC-1295 (no DAC)MKM-2603-V2347Janoshik2026-Q399.283.63Supplier-supplied1MARGINAL
AX-2026-042942AdipotideMKM-2606-K4013VendorInvestigate2026-Q397.045.5694.6Buyer-sourced1FAIL
AX-2026-042914GonadorelinMKM-2604-A2596Janoshik2026-Q299.935.19Supplier-supplied0PASS
AX-2026-042884BPC-157MKM-2605-X2575Nordanalyt2026-Q298.122.89Laboratory-retained1MARGINAL
AX-2026-042946TirzepatideMKM-2601-L3752Medutest2026-Q297.718.10Supplier-supplied1FAIL
AX-2026-042911GonadorelinMKM-2604-A2596Medutest2026-Q299.085.55Buyer-sourced1MARGINAL
AX-2026-042932L-Glutathione (reduced)MKM-2511-F2902Janoshik2026-Q298.578.4192.9Supplier-supplied1MARGINAL